Job Summary

The Senior Mechanical Engineer, is a self-starter who can play a key contributor role in our hardware development team. In this role you will plan, analyze and implement the designs and improvements to the mechanical systems in Ivenix products to achieve product performance goals and business objectives.

Salary Range: $145,000 - $160,000

• Position is eligible to participate in a bonus plan with a target of 10% of the base salary (include only if applicable to the grade level)
• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
• Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

This position is onsite 3 days per week

Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future.

Responsibilities

• This Engineer will design and develop components and subassemblies used in durable and consumable equipment designed by Ivenix.  Display standard engineering principles to resolve difficult problems, from conception to final design with team input.  Design complex electro-mechanical mechanisms.  Define, and demonstrate design meets engineering performance goals.
• Independently define components, material specifications, and process techniques to ensure proper functionality and long-term performance.  Optimize designs for low-cost, high quality, high reliability and high-volume assembly.
• Generates GD&T drawings identifying critical dimensions according to tolerance stack up analysis and manufacturing process capabilities.
• Performs and leads DFMEA according to product / system functional analysis, and updates designs (3D and 2D) and solutions accordingly.
• Establish engineering design documentation including Design files, technical records and engineering changes.
• Identify risks and resolve issues that may negatively impact project schedules and identify solutions to improve project schedules. Investigate new technologies and best practices.  Guide the conceptualization of new methodologies and processes into implementation.
• Prototype, debug, troubleshoot, and/or rework devices while maintaining quality technical documentation.  Build and test prototypes to verify design function  
• Establishes and performs DoE to assess and characterize new solutions and designs.
• Design and develop processes, tools or fixtures for assembling and testing products.
• Perform and document failure analysis of returned product
• Work with manufacturing departments to ensure final design is properly executed in the creation of mechanical products

All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities

Requirements

The requirements listed below are representative of the knowledge, skill, and /or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

•    BS or MS Degree in Mechanical Engineering or Biomedical Engineering

•    8+ years of experience as a mechanical design engineer on product development teams 

•    Direct experience developing within a regulated environment (Medical, Aerospace, Military)

•    Experience designing complex electro-mechanical assemblies in SolidWorks or other CAD system.

•    Experience in selecting appropriate materials and fabrication methods based on engineering requirements. 

•    Experience using PDM to manage database and drawing revisions in accordance with FDA requirements 

•    Design for Manufacturing (DFM) or New Product Introduction experience

•    Experience with system integration challenges such as thermal management of electronics, injection molded part design, and design for reliability.

•    Attention to details, natural inclination to be methodical and hands-on in a R&D lab environment.

•    Task management skills with ability to prioritize multiple assignments.

•    Strong problem solving and analytical skills.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.